MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-16 for MEDTRONIC 2X4 POCKET ADAPTOR 64002 NA manufactured by Medtron Ic Neuromodulation.
[53334232]
On (b)(6) 2016 pt had surgery to replace depleted dbs generator. On (b)(6) 2016 pt's essential tremors poorly controlled. On (b)(6) 2016 pt taken back to surgery to determine cause. Surgeon identifies pocket adapter as source of high impedance. Pocket adapter replaced. Old pocket adapter returned to manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5906812 |
| MDR Report Key | 5906812 |
| Date Received | 2016-08-16 |
| Date of Report | 2016-08-12 |
| Date of Event | 2016-02-25 |
| Date Facility Aware | 2016-02-25 |
| Report Date | 2016-08-12 |
| Date Reported to FDA | 2016-08-12 |
| Date Reported to Mfgr | 2016-08-12 |
| Date Added to Maude | 2016-08-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDTRONIC 2X4 POCKET ADAPTOR |
| Generic Name | DEEP BRAIN STIMULATOR POCKET ADAPTER |
| Product Code | PJS |
| Date Received | 2016-08-16 |
| Returned To Mfg | 2016-02-26 |
| Model Number | 64002 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRON IC NEUROMODULATION |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-16 |